Device recall
Z-0603-2020: Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The…
FDA device recall · Class II · Miami Device Solutions, LLC.
Key facts
| Recall number (Z-number) | Z-0603-2020 |
|---|---|
| Recall event | 84230 |
| Product | Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20. The screws can… |
| Product code | HRS |
| Recalling firm | Miami Device Solutions, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2020 |
| 510(k) numbers | K141493 |
| FEI number | 3009222247 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database